FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
68682-103
11-digit product format
686820103
Labeler code
68682
Product ID
68682-103_303dda9b-8a02-68c8-e063-6294a90a2d5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
ANDA075492
Marketing category
ANDA
Marketing start
2000-02-28
Substance
DICLOFENAC SODIUM
Active strength
100 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855657

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68682-103-01Diclofenac Sodium100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-103-01EA - Each68682-103cddf5690-7361-43b8-8878-34825d0da3cc12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-103DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]9Current NDC, Legacy NDC, 1 package rows20250316_c48113e0-9f1e-4086-b18f-3204c0d2a689.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNd9698809-4887-4514-aa28-0066355ef90810
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDd9698809-4887-4514-aa28-0066355ef90810
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYd9698809-4887-4514-aa28-0066355ef90810
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNc48113e0-9f1e-4086-b18f-3204c0d2a6899
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDc48113e0-9f1e-4086-b18f-3204c0d2a6899
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYc48113e0-9f1e-4086-b18f-3204c0d2a6899
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSN49013aad-475c-4efb-84c6-15a5d4664fbf6
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCD49013aad-475c-4efb-84c6-15a5d4664fbf6
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSY49013aad-475c-4efb-84c6-15a5d4664fbf6
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNd70fcd8e-a72b-41ef-ac26-e0f2f279f0624
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSN85ba4872-19db-2316-e053-2991aa0a00fc4
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNecaa39b8-067c-80d7-e053-2a95a90a73544
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDd70fcd8e-a72b-41ef-ac26-e0f2f279f0624
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCD85ba4872-19db-2316-e053-2991aa0a00fc4
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDecaa39b8-067c-80d7-e053-2a95a90a73544
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYd70fcd8e-a72b-41ef-ac26-e0f2f279f0624
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSY85ba4872-19db-2316-e053-2991aa0a00fc4
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYecaa39b8-067c-80d7-e053-2a95a90a73544
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNabacf60f-0410-e6da-e053-2995a90a413c3
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDabacf60f-0410-e6da-e053-2995a90a413c3
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYabacf60f-0410-e6da-e053-2995a90a413c3
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNaeda6c4e-d6fe-4ca6-968f-96214ed48f2f2
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDaeda6c4e-d6fe-4ca6-968f-96214ed48f2f2
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYaeda6c4e-d6fe-4ca6-968f-96214ed48f2f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-103-0168682010301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-103-01) 2000-02-280000-00-00NoNoCurrent